Uncertainty in Clinical Trials, Approval and Launch
First written in FY2017. 5 of 19 entries say "Restated". Latest entry: FY2027-H1.
SanBio moved to the "Worse" side of this theme in 2019, 1 year before the typical company in this theme (2020).
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
28 other companies' latest entry also says "Restated".
- FY2027-H1RestatedAnnual report
「During the interim consolidated accounting period, there were no new business risks or material changes to the business risks described in the securities report for the previous fiscal year.」
The company stated that there had been no new business risks or material changes to existing risks. - 2026-05-13MitigatedRevision of earnings forecasts
「The final drug price and insurance coverage are scheduled to be confirmed through the Ministry of Health, Labour and Welfare’s notice in the Official Gazette dated 20 May.」
Approval by Chuikyo of the proposed drug price reduced uncertainty regarding the drug price and insurance coverage by one stage. Final confirmation through the Official Gazette remained outstanding. - FY2026ReframedAnnual report
「Going forward, we plan to accelerate the rollout of アクーゴ® in Japan, conduct post-marketing clinical studies and other activities within the 7-year manufacturing and marketing approval period, which is the second approval condition, and obtain full approval. However, if the process does not proceed as expected because of an unforeseen event during regulatory review, this could have a material effect on our Group’s operating results and future business development.」
The focus of risk has shifted from uncertainty before the approval application and conditional approval to uncertainty surrounding rollout after conditional approval, post-marketing clinical studies and the process through to full approval. - FY2025MitigatedAnnual report
「As of today, one manufacturing run has met all standards in specification testing and characterization and has been determined to conform. Manufacturing for the remaining conforming run has already begun. If it conforms, we will use the results to apply for partial changes to the approved manufacturing and marketing particulars and seek approval to lift the shipping restriction.」
Although uncertainty remains because an additional conforming manufacturing run and approval for partial changes are required to lift the shipping restriction after approval, the first commercial manufacturing run has been determined to conform, and the remaining steps have become concrete. - FY2025-H1MaterialisedAnnual report
「The product cannot be shipped until the application for partial changes to the approved particulars has been approved.」
The focus has shifted from uncertainty before approval to the risks of delays in confirming quality equivalence and comparability after conditional approval, obtaining approval for partial changes to the approved particulars, beginning shipments, and selecting hospitals and patients. Because of the approval conditions, the product is currently unable to be shipped. - FY2025-Q1ReframedAnnual report
「The Pharmaceutical Affairs Council’s Regenerative Medicine Products and Biologically Derived Technologies Subcommittee, to be held on 19 June 2024, will deliberate whether to approve SB623, which we are developing, but the outcome of the deliberation cannot be predicted at this time.」
The focus of approval uncertainty has shifted from responding to quality-related additional data to the inability to predict the approval decision at the Pharmaceutical Affairs Council meeting on 19 June 2024. - FY2024ReframedAnnual report
「Following the deliberations, we understand that the clinical issues were assessed as having sufficient significance for the product to be provided in clinical practice, and that the issues relating to approval have therefore been narrowed to quality-related matters.」
The focus of approval uncertainty has shifted from the clinical significance of the product to quality-related issues after the deliberations and the submission of additional data. - FY2024-Q3RestatedAnnual report
「The timing of approval is not determined by our company, but we aim to obtain approval in March 2024.」
It has been reaffirmed that, although the company cannot determine the timing of approval, it aims to obtain approval in March 2024 following PMDA review and other procedures. - FY2024-Q1RestatedAnnual report
「The timing of approval is not determined by our company, but we aim to obtain approval during the current fiscal year.」
It has been reaffirmed that, although the company cannot determine the timing of approval and must address PMDA review and the issue of reduced yield, it aims to obtain approval during the current fiscal year. - FY2023WorsenedAnnual report
「To obtain approval, we are addressing regulatory review matters and issues relating to yield, which has decreased compared with the time of application, and aim to obtain approval during the current fiscal year.」
In addition to the review risk after submission, a manufacturing issue involving a decline in product yield compared with the time of application has been identified, making the uncertainty surrounding approval and commercialization more concrete. - FY2022ReframedAnnual report
「However, if the process does not proceed as we expect because of an unforeseen event during regulatory review, this could have a material effect on our Group’s operating results and future business development.」
The focus of approval uncertainty has shifted from the risk of a delayed application before submission to uncertainty surrounding the regulatory review process after submission. - FY2021-Q3WorsenedAnnual report
「However, we currently expect that the application planned for the fiscal year ending January 2021 is likely to be delayed.」
The expected delay in the domestic approval application has been specifically indicated, increasing the risk surrounding the timing of approval amid uncertainty over clinical trials, approval and commercialization. - FY2020RestatedAnnual report
「Although analysis results obtained in January 2019 showed that the primary endpoint had not been met, we decided to continue development with the aim of global expansion, determined the design of the next clinical trial, and will consider conducting the trial from the fiscal year ending January 2021 onward.」
The failure to meet the primary endpoint in the chronic-stage cerebral infarction trial and the subsequent policy of continuing development have been reaffirmed. - FY2020-Q3WorsenedAnnual report
「As a reason for terminating this agreement, the company stated that the Phase 2b clinical trial launched in 2015 produced results in January 2019 showing that its primary endpoint had not been met. Following detailed analyses, the two companies discussed their future direction and agreed to terminate the agreement.」
Following the failure to meet the primary endpoint in the Phase 2b trial for chronic-stage cerebral infarction, the joint development agreement was terminated, further concretizing the uncertainty surrounding development, approval and commercialization. - FY2020-Q1RestatedAnnual report
「Meanwhile, although the Phase 2b clinical trial of the SB623 chronic-stage cerebral infarction program, conducted in the United States jointly with Dainippon Sumitomo Pharma Co., Ltd. in 163 subjects, produced analysis results in January 2019 showing that its primary endpoint had not been met, we decided to continue development with the aim of global expansion.」
The fact that the primary endpoint was not met in the Phase 2b trial for chronic-stage cerebral infarction has been reaffirmed. - FY2019MaterialisedAnnual report
「In January 2019, the Phase 2b clinical trial of the SB623 chronic-stage cerebral infarction program, conducted in the United States jointly with Dainippon Sumitomo Pharma Co., Ltd. in 163 subjects, produced analysis results showing that its primary endpoint had not been met.」
The primary endpoint was not met in the Phase 2b trial for chronic-stage cerebral infarction, an event illustrating the risk that useful efficacy may not be confirmed in clinical trials and development may not proceed as planned. - FY2017First statedAnnual report
「The development of prescription pharmaceuticals requires substantial R&D investment and many years, but development often fails to proceed as planned because, among other reasons, useful effects cannot be identified in clinical trials, leading to decisions to extend or discontinue development.」
The company has disclosed the risks that efficacy may not be confirmed in clinical trials, development may be extended or discontinued, approval may be delayed, and commercialization may be abandoned.